UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Title of the study (Brief title)	Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Region	Japan

Condition
Condition	lung and mediastinal disease
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We use the da Vinci S(Si) Surgical System for thoracic diseases and evaluate afety and efficacy of robotic surgery for thoracic surgery fields in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Robotic surgery is an effective surgical method. 1.Operation time and operative blood loss 2.Intraoperative and postoperative complication 3.Postoperative progress 4.Pathological finding
Key secondary outcomes	1.Disease free survival 2.Overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Robot-assiated surgery using da Vinci S (Si) Surgical System for lung or mediastinal disease 15 cases
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with a document agreement, who is recommended for resection for the lung or mediastinal disease under thoracoscopic surgery
Key exclusion criteria	Patients who is not recommended for resection for the lung or mediastinal disease under thoracoscopic surgery,or patients whom the principal investigator or the assignment researcher judges to be unsuitable to this research paticipation
Target sample size	15

Research contact person
Name of lead principal investigator	Meinoshin Okumura
Organization	Osaka University Hospital
Division name	Department of General Thoracic Surgery
Address	2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3152
Email	meinosin@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person	Yasushi Shintani
Organization	Osaka University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Address	2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3152
Homepage URL
Email	yshintani@thoracic.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital, Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 25 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 25 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016989